De­liv­er­ing CNS-fo­cused pa­tient in­no­va­tions

End­points Stu­dio Q&A with Kei­th Kendall, CEO of Aque­s­tive Ther­a­peu­tics

The route to be­com­ing the spe­cial­ty phar­ma com­pa­ny Aque­s­tive is to­day — with a mix of com­mer­cial­ized prod­ucts and in­ves­ti­ga­tion­al med­i­cines in the clin­ic — start­ed with a tech­nol­o­gy called Pharm­Film®. End­points pub­lish­er Ar­salan Arif spoke with CEO Kei­th Kendall about the com­pa­ny’s tech­nol­o­gy, its evo­lu­tion in­to a spe­cial­ty phar­ma­ceu­ti­cal com­pa­ny, and its ap­proach to bring­ing val­ue to pa­tients and in­dus­try part­ners.

End­points Stu­dio

Could you give read­ers a brief in­tro to Aque­s­tive?

Kei­th Kendall, Aque­s­tive

We use our tech­nol­o­gy to solve prob­lems that pa­tients have in­ter­act­ing with their pre­scribed med­ica­tions. We work to im­prove dose ac­cu­ra­cy, med­ica­tion ab­sorp­tion, and ad­dress med­ica­tion de­sign chal­lenges that fac­tor in­to poor ad­her­ence. By in­no­vat­ing treat­ment for­mu­la­tions, we try to im­prove the treat­ment ex­pe­ri­ence and out­comes for pa­tients.

End­points Stu­dio

Why the fo­cus on CNS?

Kei­th Kendall, Aque­s­tive

Al­though our Pharm­Film® tech­nol­o­gy is broad­ly ap­plic­a­ble, and we have projects out­side of CNS, we chose to fo­cus our ini­tial pipeline de­vel­op­ment ef­forts on this space for a cou­ple of rea­sons.

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First, CNS pop­u­la­tions of­ten have dif­fi­cul­ty ad­her­ing to treat­ment and get­ting the op­ti­mal dose of a med­ica­tion. These pa­tients have a high­er in­ci­dence of dys­pha­gia — or dif­fi­cul­ty swal­low­ing. Some con­di­tions al­so lead to cog­ni­tive im­pair­ment, which can make pa­tients re­sis­tant to be­ing dosed. These are is­sues for care­givers and ul­ti­mate­ly for the pa­tient as well. Our tech­nol­o­gy and know-how can add a great deal of val­ue by pro­vid­ing med­ica­tions in high­ly dose-able forms that are suit­able for use in dif­fer­ent care set­tings.

Ad­di­tion­al­ly, as we trans­form our com­pa­ny in­to a spe­cial­ty phar­ma com­pa­ny that com­mer­cial­izes its own prod­ucts, the CNS space rep­re­sents a man­age­able call point for our field team. We can be more ef­fi­cient and build stronger com­mu­ni­ty re­la­tion­ships with a fo­cused sales force that car­ries mul­ti­ple prod­ucts with rel­e­vance for their cus­tomers. For ex­am­ple, our cur­rent prod­uct in the mar­ket, Sym­pa­zan, and what we hope to be one of our next prod­ucts, Liber­vant [a buc­cal film for­mu­la­tion of di­azepam that is still un­der in­ves­ti­ga­tion] are both treat­ments for epilep­sy – and have around a 90% over­lap in pre­scribers.

End­points Stu­dio

You men­tioned the trans­for­ma­tion of Aque­s­tive in­to a spe­cial­ty phar­ma­ceu­ti­cal com­pa­ny. Could you share some of the chal­lenges and op­por­tu­ni­ties be­hind that move?

Kei­th Kendall, Aque­s­tive

Aque­s­tive was orig­i­nal­ly formed back in the ear­ly 2000s on the the­sis that its tech­nol­o­gy could be li­censed and used to en­hance nu­mer­ous prod­ucts in the mar­ket. While part­ner­ing re­mains im­por­tant to us, we’ve al­so worked to evolve our busi­ness mod­el to dri­ve more growth and op­por­tu­ni­ty.

Af­ter some ex­am­i­na­tion, we rec­og­nized that bio­phar­ma com­pa­nies are re­ward­ed for three things: clin­i­cal, reg­u­la­to­ry, and com­mer­cial suc­cess. It’s dif­fi­cult for a con­tract man­u­fac­tur­er to con­trol these fac­tors. So, with the twin goals of cre­at­ing max­i­mum val­ue for our share­hold­ers and ful­ly ex­ploit­ing the strength of our tech­nol­o­gy and its ap­plic­a­bil­i­ty for pa­tients, we saw an op­por­tu­ni­ty to mi­grate in­to a spe­cial­ty phar­ma com­pa­ny.

Our plan fo­cused strate­gi­cal­ly on three things: One, de­vel­op­ing our own prod­ucts. Two, com­mer­cial­iz­ing those prod­ucts to max­i­mize the eco­nom­ic re­turn for the de­vel­op­ment work we do. And three, con­tin­u­ing to in­vest in the core tech­nolo­gies that make up our prod­ucts and en­hance their us­abil­i­ty for pa­tients.

In 2014, we em­barked on that path. And we see this strat­e­gy be­gin­ning to yield the re­sults we want­ed.

We’re very proud of our first com­mer­cial prod­uct and the ac­cep­tance it’s got­ten in the Lennox-Gas­taut syn­drome (LGS) com­mu­ni­ty. And, we’re look­ing for­ward to the po­ten­tial Liber­vant may of­fer pa­tients with clus­ter or break­through seizures, if ap­proved by the FDA.

The Epilep­sy Foun­da­tion es­ti­mates that as many as 3.4 mil­lion peo­ple in the U.S. have epilep­sy. A re­cent study in 300 adult pa­tients with ac­tive epilep­sy in­di­cat­ed that, when fol­lowed for a year, near­ly half had seizure clus­ters. Res­cue med­ica­tion was un­der­uti­lized in this pop­u­la­tion, but when used, it was as­so­ci­at­ed with few­er in­juries and emer­gency de­part­ment vis­its. The pri­ma­ry di­azepam prod­uct that’s avail­able to them now is a rec­tal gel, which many pa­tients sim­ply will not use. We’re in­ves­ti­gat­ing a nov­el, oral di­azepam treat­ment that’s de­signed for res­cue sit­u­a­tions. We’re very proud of the work that’s gone in­to re­search­ing this po­ten­tial ad­vance.

All of this re­flects our strat­e­gy com­ing to fruition.

End­points Stu­dio

Could you talk about your per­spec­tives on part­ner­ing? As you ap­proach in­dus­try and med­ical con­fer­ences, what kind of op­por­tu­ni­ties are you look­ing for?

Kei­th Kendall, Aque­s­tive

Aque­s­tive is built on a fun­da­men­tal prin­ci­ple around col­lab­o­ra­tion and part­ner­ing – work­ing to­geth­er to solve prob­lems and bring mean­ing­ful new med­i­cines to the mar­ket. And if you look at the prod­ucts in our port­fo­lio, you can see good ex­am­ples of that.

We be­lieve we have knowl­edge, tech­nol­o­gy, and in­tel­lec­tu­al prop­er­ty that are broad­ly ap­plic­a­ble – and may im­prove how med­ica­tions are used by pa­tients. But we’ll nev­er be able to in­vest in, and do jus­tice to, every op­por­tu­ni­ty on our own. As such, we seek part­ners that have a chal­lenge de­sign­ing pa­tient-friend­ly med­ica­tions or op­ti­miz­ing med­ica­tion ad­min­is­tra­tion. We be­lieve our ex­per­tise and tech­nol­o­gy can help ad­vance their med­ica­tions.

Sub­ox­one® is a great ex­am­ple of what our Pharm­Film tech­nol­o­gy can do for in­dus­try part­ners – cre­at­ing a strong fran­chise that ad­dress­es re­al needs in the mar­ket. In spite of both brand­ed and new gener­ic com­pe­ti­tion, that prod­uct con­tin­ues to be very suc­cess­ful. We’re very pleased that we cre­at­ed a prod­uct that has that much util­i­ty and that earned strong pref­er­ence among providers and pa­tients.

End­points Stu­dio

Switch­ing gears a bit, can you tell me a lit­tle bit about your­self and your back­ground? Can you tell me about how you got in­to the in­dus­try? I un­der­stand you’re not orig­i­nal­ly “from” bio­phar­ma?

Kei­th Kendall, Aque­s­tive

Yes, I’m not a “na­tive” bio­phar­ma ex­ec­u­tive. I spent the ear­ly part of my ca­reer in fi­nan­cial ser­vices. I sup­pose that the orig­i­nal in­vestors in this com­pa­ny rec­og­nized that there were two kinds of skills they need­ed at the ex­ec­u­tive lev­el. The first is sci­en­tif­ic ex­per­tise to de­vel­op prod­ucts the right way. The oth­er is busi­ness ex­pe­ri­ence — some­one fa­mil­iar with build­ing or­ga­ni­za­tions, rais­ing mon­ey and deal­ing with share­hold­ers.

This is the fifth start­up or turn­around com­pa­ny that I’ve led. So I un­der­stand how to build an or­ga­ni­za­tion that can ma­ture and grow, by tak­ing on more com­plex work — like Aque­s­tive.

I’m par­tic­u­lar­ly proud of the cul­ture we’ve cre­at­ed at Aque­s­tive. As our name im­plies, we are pas­sion­ate about “the quest” to cre­ate in­no­v­a­tive treat­ments that solve prob­lems pa­tients have tak­ing med­ica­tions in their cur­rent form. That work is com­plex. But we know that by work­ing to­geth­er, we can iden­ti­fy for­mu­la­tion ad­vances and de­sign med­i­cines that re­al­ly fit in­to pa­tients’ lives. And those are mean­ing­ful con­tri­bu­tions to their care.

Learn more about Aque­s­tive here.

Pa­tients should speak to their health­care provider to de­ter­mine what treat­ments are best for them. For more in­for­ma­tion, in­clud­ing im­por­tant safe­ty in­for­ma­tion, peo­ple should vis­it: https://www.sym­pa­zan.com/pdfs/pi.pdf.